Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making (RECOMMEND)

Peking University

Status: Unknown

Conditions: Gastric Cancer

Treatments: Drug: ACT; Procedure: SDM; Drug: NACT; Procedure: Surgery; Other: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT03413514

2017YJZ51

Details and patient eligibility

About

The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.

Full description

The study is a non-randomized clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. MRI and enhanced CT are used to evaluate the clinical response of the tumor. The primary endpoint is the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically proven adenocarcinoma of the stomach
2. Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy.
3. Receive neoadjuvant chemotherapy in clinical

Exclusion criteria

1. Contraindication for chemotherapy
2. Contraindication for surgery
3. Clinically apparent distant metastasis

Trial design

100 participants in 1 patient group

experiment group

Experimental group

Description:

Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.

Treatment:

Other: Questionnaire

Drug: NACT

Procedure: SDM

Drug: ACT

Procedure: Surgery